Clinical Research Data Entry

Name-Neetu Chawla

Email- **************@*****.***

LinkedIn - https://www.linkedin.com/in/neetu-chawla-573a1515/

Phone # 661-***-****

California-USA

Objective

Detail-oriented and highly organized clinical research professional with 8 years of experience in clinical trials, including trial site start up, data collection, regulatory compliance, and patient recruitment. Proven track record of effectively managing all phases of clinical research while ensuring adherence to protocols and regulatory guidelines. Adept at collaborating with cross-functional teams and maintaining accurate records for data integrity and reporting.

Clinical Research Coordinator II Experience:

~8 years’ experience in COVID, Parkinson, Cardiovascular diseases, Pulmonary/ Asthma and COPD, Narcolepsy, Lupus & Sjogren’s disease (device trial) Neurology and Dermatology, URT therapeutic area, Phase II, III, IV and Bioequivalence studies.

Successfully managing/leading multiple clinical trials at a time from subject recruitment to study completion. Train new coordinators for studies. Attending Investigator Meetings around the US and assigned as Lead Coordinator for clinical trials and back up for other ongoing trials.

Clinical trial activities, including creating source documents, site logs, subject recruitment, enrollment trackers, data collection, coordinating with central lab and sponsor, IMP accountability (IWRS), query resolution, e-Diary dispensing, performing PFTs, FENO. EDC experience in IBM, Oracle, Medidata Rave, CompleWare’s electronic patient reported outcomes (ePRO) data entry and query resolution for Asthma and COPD studies.

Sound knowledge of clinical research laws and procedures, including patient consent, e-consent, remote visits, performing screening to test eligibility, and ensuring accurate documentation. Understanding in drug and device clinical study, different phases and regulatory requirements for device and drug study. IRB submission, Protocol amendments submission, Adverse events reporting, maintaining regulatory binders.

Experience with Audits, SIV and close out visits.

Experience with CRIO, sales force, Florance, Veeva site Vault, CompleWare’s electronic patient reported outcomes (ePRO) data entry for Respiratory trials, Science37 platform for all trials, JIRA tickets, Excel, Power point, creating meeting minutes documents during sponsor meeting and keeping track of completion of the tasks.

Study startup Experience:

Experience in preparing Study startup documents. IRB submission, Review Consent forms, developing slides for KOM, Creating Workflow for CRCs, helping Study manager in developing study slides deck. Creating Platform guidelines for new studies. UAT testing (trial platform).

Creating and maintaining spreadsheets for tracking visits and scheduling all future visits.

Creating workflow for QC during and after study enrollment. QC all study visits for other CRCs and generating queries. Preparation for external Audit.

IMP / Device shipment workflow

Mentors/Training newly onboard CRCs

Enrolling /Managing 150+ Participant for one study.

Helping study lead during and before Audits

Experience with Florance e Binders, training logs maintenance, Regulatory binders

Recruitment /Patient Engagement/ Maintain Sites -Set up training for site users in sales force/ Follow up regarding site need, enrollment, maintaining training logs, Coordinating with sites weekly for enrollment matrix.

TMF/ Regulatory approval.

Education/ Certification and Training

Bachelor’s in Pharmaceutical Sciences, (M.D.U.), India, 2003

SOCRA Certification; Continuing Education, Regulatory Updates for Clinical Research Professionals-SOCRA - How to Create a Protocol Draft.

SOCRA - ICH GCP E6 (R2): From the site’s perspective

Regulatory Affairs for Medical Devices: (UCSD San Diego)

Clinical Research Coordinator Certification (CITI Program) CCRC 2024

GCP Training for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus), (CITI Program)

Certified Medical Assistant, Golden Oak Adult School, 2017, NHA (National Health Care Association)

Skills-

Study start up, Operations, CTMS, Excel, Word, CRIO, sales force, Florance, Veeva site Vault, CompleWare’s electronic patient reported outcomes (ePRO) data entry for Respiratory trials, Science37 platform for all trials, JIRA tickets, Excel, Power point.

Experience

Science37- Nov 2020- 2025

Clinical research Coordinator II/ Study start up -Decentralized trials

Successfully completed multiple trials Remotely and managed start to complete 100+ participants for each study.

Helping the study manager in preparation of KOM slides deck, review/creating dispositions forms for participant communications/visits for dial pad/Five 9 channels.

Creating study start up documents, training log, CRC workflows, visits tracking spread sheets, IMP/ Device workflow,

Review of new protocol, develop enrollments strategies, consent review. Documents all version in e-binders.

Creating Platform guidelines for new trials.

Creating eCRF completion guidelines for new studies.

UAT testing

Experience in Excel spreadsheets, MS Word, JIRA tickets, ePRO, platform, CTMS, CRIO, eTMF, Sales force, educate participants to use S37 APP and other devices required for the study.

Conducting e-Consents, Scheduling Nurses and Investigator’s visit for screening, Randomization, follow up visits. Remote visits experience via platform zoom call and Data entry in real time for Platform and EDC.

Closely monitoring participant and reporting AE/ SAE in real time.

Creating QC documentation and QC visits for other CRCs.

Collaborating across supply chain, recruitment team, nursing team, finance team for study operations.

Study closeouts visit and queries resolutions.

Attending sponsor meetings regularly.

Training new CRC for e-consent/ LAR and platform visits, documentation. Maintaining training records.

Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.

Participates during sponsor’s conducted Initiation, Interim and Closeout monitoring visits.

Participates Recruitments studies-

Site management, experience with Salesforce recruitment, CRIO.

Site Training set up and follow up for portal access. Maintaining all sites training logs. Follow up all the sites for patient status. Generating reports for each site for the Sponsor.

Reviewing medical records for participants’ eligibility and assigned to sites.

Cedars Sinai Medical Tower, Los Angeles, CA: Sep 2018 – 2020

Lead Clinical Research Coordinator

Therapeutic area: Asthma, COPD, Narcolepsy, (Injections, Inhaler, Bioequivalence Study

Prepare and participate in conducting patient and study visits.

Manages regulatory documents (ICFs, Training logs, IRB communications, site logs) and clinical trial manuals.

Creates source documents according to protocol and data collection charts.

Attending Investigator Meetings around the USA. Lead Coordinator for clinical trials and back up for other ongoing trials.

Developing forms for sites, questionnaires for patients, completing, and submitting CRN logs.

Reporting SUSAR/ AEs.

EDC experience IBM, Oracle, and Medidata Rave. Including data entry, query resolution.

Coordinates with central labs and sponsor, monitor.

Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.

Participates during sponsor’s conducted Qualification, Initiation, Interim and Closeout monitoring visits.

For Asthma study performing spirometry and FeNO test during subject’s visits.

Clinical Research Coordinator: Axis Clinical Trials- 2018

Therapeutic area: Skin, Eczema, dermatitis, alopecia, seizure, Vaginitis

Assisted in recruiting potential subjects. Scheduled patients within inclusion criteria. Phone screen patients. Assisted during patient visits.

Responsible for data collection, completion of CRFs and data management inputting into appropriate EDC.

Responsible for blood collection and processing lab samples and perform EKG, taking vitals on follow up visit.

Monitor patients’ progress to include documentation and reporting of adverse events.

Collected and recorded data on Case Report Forms (CRFs) for clinical research protocol.

Ensure that all study related activities are complete including returning supplies, returning unused stock of study drug, and confirming that all queries are complete.

Assisted in maintaining regulatory binders, creating source documents.

Participated during SIV (site initiation visit).

SOCAL Neurological Center, Santa Clarita, CA: 2017- May2018

Clinical Research Coordinator

Therapeutic area: Neurology (Alzheimer’s Disease)

Coordinated clinical trial for Alzheimer’s disease. Completed all training required for clinical trial (CDR, MMS, IATA, C-SSRS, EKG, Oracle- EDC

Conducted study coordination and screened potential patients for protocol eligibility.

Coordinated and implemented procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources, SD.

Collected, processed and shipped laboratory specimens, performed EKG and vitals on follow up visit.

Monitor patients’ progress to include documentation and reporting of adverse events.

Collect and record data on Case Report Forms (CRFs) for clinical research protocol.

Ensure that all study related activities are complete including returning supplies, returning unused stock of study drug, and confirming that all queries are complete.

Assisted in maintaining regulatory binders.

Interact with and maintained close communication with the sponsor’s Clinical Research Associate to facilitate the sponsor monitoring.

Ensure compliance with IRB approved protocol guidelines.

Clinical Research Coordinator (2003-2004) INDIA

Worked with and under the Principal Investigator; supported, facilitated, and coordinated the daily clinical trial activities, collected data as required by protocols.

Responsible for conducting evaluation, initiation, and routine monitoring and close out visits at each assigned study site and worked in conjunction with the in-house project teams to ensure that sites have adequate study drugs and supplies.

Responsible for accurate and timely data collection, documentation, entry, and reporting and reviewed study files and update tracking information reported for key study forms.

Experience in bioequivalence-studies.

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